Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UG3DE030433-01A1 | U.S. NIH Grant/Contract | View source | |
| UH3DE030433 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
Not provided
Not provided
Not provided
Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Active PBM | Experimental | PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD. |
|
| Sham PBM | Sham Comparator | When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THOR® laser system | Device | We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level Change with PBM treatment using a Numerical Rating Scale | The primary outcome measure will be the average of daily pain ratings on the numerical rating scale (0 = no pain, 100 = worst pain imaginable) from the Daily Symptom Diary. Daily pain ratings averaged over one week prior to randomization will be treated as the baseline variable. The average daily pain for one week prior to Visit 9 will be treated as the primary endpoint. This outcome measure averaged across multiple days provides a stable measure of pain that is less subject to recall bias. | Through study completion; about 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selenia Rubio, MD | Contact | 352-273-5590 | srubio7@ufl.edu | |
| Eric Weber, CCRP | Contact | 352-273-7802 | ebweber@ufl.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41436122 | Derived | Rodriguez MG, Warchol M, Rubio S, Cabrera P, Reever R, Hosney S, Migliorati CA, Gibson Iii FC, Ohrbach R, Fillingim RB, Wallet S, Ribeiro Dasilva MC. In vitro effects of dual wavelength photobiomodulation on monocytic response in painful temporomandibular disorder. J Oral Facial Pain Headache. 2025 Dec;39(4):252-257. doi: 10.22514/jofph.2025.082. Epub 2025 Dec 12. | |
| 41399628 | Derived | Rubio S, Cabrera P, Reever R, Migliorati C, Ohrbach R, Gibson FC 3rd, Li Z, Mickle A, Conic RRZ, Fillingim RB, Ribeiro Dasilva M. A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults. Contemp Clin Trials Commun. 2025 Nov 24;48:101571. doi: 10.1016/j.conctc.2025.101571. eCollection 2025 Dec. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|